150 mg and 500 mg film-coated tablets of 
capecitabine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects. talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Capecitabine Orion is and what it is used for 
2. What you need to know before you take Capecitabine Orion 
3. How to use Capecitabine Orion 
4. Possible side effects 
5. How to store Capecitabine Orion 
6. Contents of the packaging and other information

What Capecitabine Orion is and what it is used for

Capecitabine Orion belongs to a group of medicines called “cytostatics”, which prevent the growth of cancer cells. Capecitabine Orion contains 150 mg or 500 mg of capecitabine, which in itself is not a cytostatic drug. Only after the body has absorbed capecitabine is it converted into an active anti-cancer drug (preferably in tumor tissue).

Capecitabine Orion is used to treat colon, rectal, gastric or breast cancer. Capecitabine Orion is also used to prevent the recurrence of colon cancer after a tumor has been removed.

Capecitabine Orion can be used either alone or in combination with other medicines.

Capecitabine contained in Capecitabine Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Capecitabine Orion

Do not take Capecitabine Orion:

  • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must tell your doctor if you know you are allergic or hypersensitive to this medicine,
  • if you have previously had severe reactions to fluoropyrimidine treatment (a group of medicines for cancer such as fluorouracil)
  • if you are pregnant or breastfeeding
  • if you have severely low levels of white blood cells or platelets ( leukopenia, neutropenia thrombocytopenia )
  • if you have severe liver or kidney problems
  • if you know that the enzyme a dihydropyrimidine dehydrogenase (DPD) is completely inactive in you
  • if you are being treated with, or within the last 4 weeks have been treated with brivudine, sorivudine or similar substances for the treatment of herpes zoster (chickenpox or shingles ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Capecitabine Orion

  • if you know that enzyme et dihydropyrimidine dehydrogenase (DPD) is partially inactive in you if you have liver or kidney disease
  • if you have or have had heart problems (for example, irregular heartbeat or chest pain,jaw or back caused by physical exertion and due to problems with blood flow to the heart)
  • if you have diseases of the brain (for example, cancer that has spread to the brain or nerve damage [neuropathy])
  • if you have disturbed calcium balance (seen in blood tests)
  • if you have diabetes
  • if you can not keep food or water in your body due to severe nausea and vomiting
  • if you have diarrhea
  • if you are or become dehydrated
  • if you have an imbalance of ions in the blood (imbalance of electrolyte is, seen in samples)
  • if you have previously had eye problems, as you may need extra eye checks
  • if you have a severe skin reaction.

DPD Deficiency: DPD deficiency is a rare congenital condition that is not usually associated with health problems unless you are given certain medications. If you have an unknown DPD deficiency and are taking Capecitabine Orion, you may be at increased risk for early and rapid onset of severe side effects listed in section 4 Possible side effects . Contact your doctor immediately if you are worried about any of the side effects or if you notice any additional side effects not listed in this leaflet (see section 4 Possible side effects ).

Children and young people

Capecitabine Orion is not indicated for use in children and adolescents. Do not give Capecitabine Orion to children and adolescents.

Other medicines and Capecitabine Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is very important as the treatment effect can be affected if Capecitabine Orion is taken at the same time as other medicines. You must be especially careful if you are taking medicine for any of the following:

  • gout (allopurinol)
  • blood thinners (coumarin, warfarin )
  • certain anti-viral medicines (sorivudine and brivudine)
  • medicines for seizures or tremors ( phenytoin )
  • interferon alfa or
  • radiation therapy and certain drugs used to treat cancer (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan)
  • drugs used to treat folic acid deficiency.

Capecitabine Orion with food, drink, and alcohol

You should take Capecitabine Orion within 30 minutes of finishing your meal.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Capecitabine Orion if you are or think you may be pregnant. You should not breast-feed while taking Capecitabine Orion.

Driving and using machines

The treatment may make you feel dizzy, nauseous, or tired after ingestion. Capecitabine Orion may therefore affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Capecitabine Orion contains anhydrous lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Capecitabine Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Capecitabine Orion should only be prescribed by a doctor who has experience in the use of anticancer medicines.

Capecitabine Orion tablets should be swallowed whole with water within 30 minutes after the end of the meal.

Your doctor will prescribe the right dose and dosage for you. Capecitabine Orion dose is based on your body surface area. It is calculated from your height and weight. The usual dose for adults is 1250 mg / m 2 body surface area twice a day (morning and evening). Two examples are given here: A person whose body weight is 64 kg and length is 1.64 m has a body surface area of ​​1.7 m 2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice a day. A person whose body weight is 80 kg and length is 1.80 m has a body surface area of ​​2.00 m2 and should take 5 tablets of 500 mg twice a day.

Capecitabine Orion tablets are normally taken for 14 days followed by a 7-day rest period (when no tablets are taken). This 21-day period is a treatment cycle.

In combination with other medicines, the normal dose for adults may be less than 1250 mg / m2 body surface area, and you may need to take the tablets for a different period of time (eg every day without any rest period).

Your doctor will tell you what dose you need to take when to take it and for how long you need to take it.

Your doctor may want you to take a combination of 150 mg and 500 mg tablets at each dose.

  • Take the tablets morning and evening as prescribed by your doctor.
  • Take the tablets within 30 minutes after the end of the meal (breakfast and dinner).
  • It is important that you take all the medicines prescribed by your doctor.

You can get the following side effects if you take much more capecitabine than you should: nausea and vomiting, diarrhea, inflammation or ulcers in the intestines or mouth, pain or bleeding from the intestines or stomach or bone marrow depression (decrease in certain types of blood cells ). Tell your doctor immediately if you experience any of these symptoms.

If you forget to take Capecitabine Orion

Do not take the missed dose one or double the next dose . Instead, continue with your prescribed dosage and talk to your doctor.

If you stop taking Capecitabine Orion

There are no side effects caused by stopping capecitabine treatment. If you are taking coumarin anticoagulants (containing eg phenprocoumon), your doctor may require you to adjust your dose of anticoagulants when you stop taking capecitabine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

STOP taking Capecitabine Orion immediately and contact your doctor if any of these symptoms occur:

  • Diarrhea : if you have an increase of more than 4 stools each day compared to your normal number of stools per day or diarrhea at night.
  • Vomiting: if you vomit more than once in a day.
  • Nausea: if you lose your appetite and the amount of food you eat every day is much less than usual.
  • Stomatitis: if you have pain, redness , swelling or sores in your mouth and / or throat.
  • Hand-foot syndrome: if you have pain, swelling, redness or tingling in your hands and / or feet.
  • Fever: if you have a body temperature of 38ºC or more.
  • Infection: if you have signs of infection caused by bacteria or viruses or other organisms .
  • Chest pain: if you feel pain from the middle of the chest, especially if it comes when you exercise.
  • Stevens-Johnson syndrome: if you have painful red or violet skin rashes that spread and blisters and / or other sores that begin to appear in the mucous membrane (eg mouth and lips), especially if you have previously been photosensitive, had an infection in the airways (t eg bronchitis ) and / or fever.
  • DPD deficiency: if you have a known DPD deficiency, you are at increased risk of acute and early onset of poisoning and severe, life-threatening or fatal side effects caused by Capecitabine Orion (eg stomatitis , mucositis, diarrhea, neutropenia neurotoxicity ).

If these side effects are detected early, they may subside within 2 to 3 days after stopping treatment. If these side effects persist, contact your doctor immediately. Your doctor may advise you to start treatment again with a lower dose.

Skin reactions on hands and feet can lead to loss of fingerprints, which may affect your fingerprint identification.

In addition to what is mentioned above, when Capecitabine Orion is used alone, very common side effects , which can affect more than 1 person in 10:

  • abdominal pain
  • skin rash, dry or itchy skin
  • fatigue
  • loss of appetite ( anorexia )

These side effects can be serious. Therefore, always contact your doctor immediately when you start to feel a side effect. Your doctor may advise you to reduce the dose one and / or to temporarily stop taking Capecitabine Orion. In this way, the risk of the side effect continuing or worsening is reduced.

Other side effects are:

Common side effects (may affect up to 1 in 10 people) include:

  • decreased number of white or red blood cells (seen in samples)
  • dehydration, weight loss
  • insomnia ( insomnia ), depression
  • headache, drowsiness, dizziness, abnormal sensation in the skin (numbness or tingling) taste changes
  • eye irritation, increased tear volume, red eyes ( conjunctivitis )
  • inflammation of the veins ( thrombophlebitis )
  • shortness of breath, nosebleeds, cough, runny nose
  • cold sores or other herpes infection
  • infection in the lungs or respiratory tract (eg pneumonia or bronchitis )
  • intestinal bleeding, constipation, upper abdominal pain, digestive problems, increased gas in the stomach, dry mouth
  • skin rash, hair loss ( alopecia ), redness of the skin, dry skin, itching , skin discoloration, skin detachment, skin inflammation, nail effects
  • joint, limb, chest, or back pain
  • fever, swelling of the extremities , malaise
  • problems with liver function (seen in blood tests) and increased amount of bilirubin in the blood (excreted by the liver)

Uncommon side effects (may affect up to 1 in 100 people) include:

  • infection of the blood, urinary tract infection, infection of the skin, infection of the nose and throat, fungal infections (including infection of the mouth), influenza , gastrointestinal catarrh , dental disease
  • lumps under the skin (lipoma)
  • decreased number of blood cells including platelets , thinned blood (seen in samples)
  • allergy
  • diabetes , decreased potassium in the blood, malnutrition, elevated blood fats
  • confusion, panic attacks, depression, decreased libido
  • difficulty speaking, impaired memory, loss of ability to coordinate movements, balance problems, fainting, nerve damage ( neuropathy ), and emotional problems
  • blurred vision or double vision
  • dizziness, earache
  • irregular heartbeat and palpitations ( arrhythmia ), chest pain and heart attack (infarction)
  • blood clots in the deep veins, high or low blood pressure , hot flashes, cold extremities , purple spots on the skin
  • blood clots in the veins of the lung ( pulmonary embolism), collapsing lung, coughing up blood, asthma , shortness of breath on exertion
  • intestinal obstruction, accumulation of fluid in the abdomen, inflammation of the small intestine, colon, stomach, or esophagus, pain in the lower abdomen, abdominal discomfort, heartburn (regurgitation of food from the stomach), bloody stools
  • jaundice (yellowing of the skin and eyes)
  • sores and blisters on the skin, skin reaction to sunlight, redness of the palms, swelling or pain in the face
  • swollen or stiff joints, skeletal pain, weakness or stiffness in the muscles
  • accumulation of fluid in the kidneys, urinating more often at night, incontinence , blood in the urine, increased creatinine in the blood (signs of impaired kidney function)
  • unusual bleeding from the vagina
  • swelling ( edema ), chills, and stiffness.

Some of these side effects are more common when capecitabine is used with other medicines to treat cancer. Other side effects seen in these cases are as follows:

Common side effects (may affect up to 1 in 10 people) include:

  • decreased amount of sodium , magnesium or calcium in the blood, increased blood sugar
  • nerve pain
  • ringing or buzzing sounds in the ears ( tinnitus ), hearing loss
  • inflammation of the veins
  • hiccups, altered voice
  • pain or altered / abnormal sensation in the mouth, pain in the jaw
  • sweating, night sweats
  • muscle cramps
  • difficulty urinating, blood or protein in the urine
  • bruising or reaction at the injection site (caused by medicines given as an injection at the same time )

Rare side effects (may affect up to 1 in 1,000 people) include:

  • narrowing or blocking of the lacrimal duct (lacrimal ductus stenosis)
  • liver failure
  • inflammation leading to dysfunction or blockage of bile secretion (cholestatic hepatitis )
  • specific changes in the electrocardiogram ( QT prolongation)
  • certain types of arrhythmia (including ventricular fibrillation, torsade de points and bradycardia )
  • eye inflammation that causes pain in the eyes and possibly vision problems
  • inflammation of the skin that causes red scaly patches due to disease emanating from the immune system

Very rare side effects (may affect up to 1 in 10,000 people) include:

  • severe skin reaction such as rash, sores and blisters that may include sores in the mouth, nose, genitals, hands, feet and eyes (red and swollen eyes).

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Capecitabine Orion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiration date is the last day of the specified month.

Aluminum / aluminum blister: No special storage instructions.

PVC / PVdC-aluminum blister: Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is capecitabine (150 mg or 500 mg per film-coated tablet).
  • Other ingredients are:
  • Tablet core : anhydrous lactose , microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate.
  • Tablet coating : hypromellose, talc, titanium dioxide (E171), yellow and red iron oxide (E172).

What the medicine looks like and contents of the pack

150 mg tablets:

Slightly peach-colored, oblong-shaped, biconvex, film-coated tablet that is 11.4 mm long and 5.3 mm wide with ‘150’ imprinted on one side and smooth on the other side.

500 mg tablets:

Peach-colored, oblong-shaped, biconvex, film-coated tablet that is 15.9 mm long and 8.4 mm wide with ‘500’ imprinted on one side and smooth on the other side.

Pack sizes: 10 film-coated tablets per blister in pack sizes of 30, 60 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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